Trial | NCT00557011  Report issue

Title

NRP104, Adderall XR or Placebo in Children Aged 6-12 Years With ADHD
A Phase 2, Randomized, Double-Blind, Placebo- and Active-Controlled, 3-Treatment, 3-Period, Crossover Study With One Week Per Treatment and Once-a-Day Dosing of Either NRP104, Adderall XR, or Placebo in Children Aged 6 to 12 Years With Attention-Deficit Hyperactivity Disorder (ADHD)

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    52
The purpose of this study is to assess, in a controlled environment, the efficacy and safety of NRP104 and Adderall XR compared to placebo in treatment of children, aged 6-12, with ADHD.
Study Started
Sep 30
2004
Study Completion
Dec 31
2004
Last Update
May 25
2011
Estimate

Drug NRP104

30 mg, 50 mg or 70 mg capsules taken orally once daily in the morning

  • Other names: lisdexamfetamine dimesylate

Drug Adderall XR

10 mg capsules taken once daily in the morning at dosages of either 1x10mg, 2x10mg or 3x10mg

  • Other names: mixed salts of a single-entity amphetamine

Drug Placebo

Placebo capsule taken once daily in the morning

1 Experimental

NRP104

2 Active Comparator

Adderall XR

3 Placebo Comparator

Placebo

Criteria 

Inclusion Criteria:

males and non-pregnant females, aged 6-12 years DSM-IV-TR criteria for diagnosis of ADHD, combined or hyperactive-impulsive subtypes
on stable regimen of stimulants for at least one month in the last six months and has shown adequate response to stimulants without unacceptable side effects

Exclusion Criteria:

co-morbid psychiatric diagnosis such as psychosis, bipolar illness, severe OCD, severe depressive or anxiety disorder
history of seizure during the last 2 years, a tic disorder or Tourette's
clinically significant ECG or laboratory abnormalities at screening or baseline
taking clonidine or anticonvulsant drugs
taking medications that affect blood pressure or heart rate
No Results Posted